1. Patients with a diagnosis of quiscent (CDAI 1 year. MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: mesalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: mesalazine
CAS Number: 65-49-6
Other descriptive name: AMINOSALICYLIC ACID
Concentration unit: mg milligram(s)
Concentration
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years or older - Mesalazine maintenance therapy >1 year - Quiescent disease (definition: CDAI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Flare-up(s) of CD within 12 months preceding inclusion - Treatment with prednisone, budesonide, infliximab, adalumimab of ceroluzimab within 12 months of inclusion - Treatment with methotrexate, mercaptopurine or azathioprine, when initiated within 6 months prior to inclusion - Extra-intestinal CD manifestations such as fistulas or pyoderma gangrenosum demanding induction therapy - Treatment with enteral or parenteral feeding within 6 months prior to inclusion - Treatment with metronidazole, ciprofloxacin, rectal steroids or rectal aminosalicylates within 12 months prior to inclusion - Previous ileo-colorectal resection, such as small bowel resections >100 cm, total proctocolectomy, subtotal colectomy, colostomy or ileostomy - Primary sclerosing cholangitis (PSC) - Hypersensitivity to mesalazine - Disorders, which are likely to require systemic steroids (e.g. asthma) - Abnormalities in liver function tests (definition: 2x upper limit of normal value of ALAT. Normal values ALAT: > 45 U/L (men) of >35 U/L (women) - Abnormalities in kidney function tests (definition: creatinin > 120 µmol/L (men) or >103 µmol/L (women) - Dysplasia or neoplasia of the colon - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. How does stopping of mesalazine affect quality of life of CD patients? 2. Does compliance to mesalazine affect outcome with regard to disease activity and quality of life? ;Main Objective: 1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD? 2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease behavior (number of prior relapses and/or development of complications, such as fistulas or strictures) or co-medication be identified, which benefit most from mesalazine maintenance therapy? 3. Is mesalazine cost-effective in a subgroup of CD patients? ;Primary end point(s): The primary endpoints are: 1. The proportion of patients who experience a clinical relapse during the 18 months follow-up period, defined as: - CDAI score above 250 or a score between 150-250 in 3 consecutive weeks with an increase of at least 75 points above the baseline value, and/or; - Need to perform surgery, and/or; - Adjustment of CD-related therapy during follow-up, for example by the addition of steroids, infliximab, methotrexate, 6-mercaptopurine or azathioprine. 2. Cost-effectiveness - To assess cost-effectiveness we will investigate total costs of mesalazine versus no mesalazine maintenance in CD patients. The economic evaluation will be performed in accordance with the Dutch guidelines20. We will take a societal perspective, and include health care costs and patient costs (e.g. work absence and travel costs). For the calculation of the health care costs of the two different treatment strategies (i.e. mesalazine or no mesalazine maintenance), we will distinguish medication costs, intramural costs (inpatients days, general practitioner activities, medical treatment) and extramural costs (home care, general practioner). Patient costs will include costs of absence from work or school (sick leave), travel costs, and time costs. Real medical c | — |
Countries
Netherlands
Outcome results
None listed